T Cells and Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma
Summary
The goal of this clinical trial is to test a combined therapy approach (allogeneic cytomegalovirus \[CMV\]-specific T cells and pembrolizumab) in patients with brain cancer. The type of brain cancer being studied is glioblastoma multiforme/astrocytoma grade 4. The purpose of part 1 of this study is to determine the maximum-tolerated dose and/or recommended dose(s) for future exploration of allogeneic CMV-specific T cells as monotherapy or in combination with pembrolizumab in patients with recurrent GBM/astrocytoma grade 4. Part 2 of the study aims to investigate the anti-tumour activity of allogeneic CMV-specific T cells as monotherapy or in combination with pembrolizumab, assessed by magnetic resonance imaging and survival, in patients with recurrent or newly diagnosed GBM/grade 4 astrocytoma.
Timeline
- Start
- 2024-02-08
- Primary completion
- 2025-10-02
- Completion
- 2028-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Allogeneic cytomegalovirus-specific T cells | Cell therapy | 2e+07 cells | — |
| Subject | Allogeneic cytomegalovirus-specific T cells | Cell therapy | 4e+07 cells | — |
| Subject | Allogeneic cytomegalovirus-specific T cells | Cell therapy | 8e+07 cells | — |
| Subject | Pembrolizumab | Monoclonal antibody | 400 mg | — |